Important Safety Information for patients
NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate) 20mg/10mg capsules are approved for the treatment of pseudobulbar affect (PBA). PBA is a medical condition that causes sudden, frequent and involuntary bouts of crying and/or laughing in people living with certain neurologic conditions or brain injuries. Studies to support the approval of NUEDEXTA were done in patients with multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). An additional safety study included a variety of other neurologic populations. NUEDEXTA is not approved to treat emotional symptoms other than involuntary crying and/or laughing that may occur with certain neurologic conditions.
NUEDEXTA and certain other medicines can interact causing serious side effects. People taking MAOIs (within the preceding or following 14 days), quinidine, or quinidine related drugs, and certain other medications should not take NUEDEXTA. Tell your doctor about all medicines, herbal supplements, and vitamins you are taking before you start or while you are taking NUEDEXTA.
Some people can have an allergic reaction to NUEDEXTA. Call your doctor right away if you experience lightheadedness, chills, fever, nausea, or vomiting while taking NUEDEXTA.
NUEDEXTA may cause serious side effects, including changes in heart rhythm (QTc prolongation). Tell your doctor if you or a family member has or ever had any heart disease or problems. If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA. If you feel faint or lose consciousness, call your doctor right away.
NUEDEXTA may make you dizzy. Be extra careful not to fall, especially if you have a hard time walking or a problem with falling.
The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, feeling like you have the flu, abnormal liver tests, and gas. These side effects were seen in 13% or less of patients taking NUEDEXTA. Those are not all the possible risks of NUEDEXTA. Tell your doctor about any side effect that bothers you or does not go away.
For more information, click here for the Full Prescribing Information. This important safety information is not meant to replace discussions with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 800-FDA-1088.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided in this site is intended only for residents of the United States. NUEDEXTA® is a registered trademark of Avanir Pharmaceuticals, Inc.
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